NIH Revision to Definition of a Clinical Trial

Please remember to download the expanded guidance document linked on the right side of this webpage. The expanded guidance document outlines the following items:

NIH Revisions to the Policies on Definition of a Clinical Trial 

  1. Revised NIH Definition of Clinical Trial
  2. Determination If Your Human Subject’s Research Study Meets the Revised NIH Definition of a Clinical Trial?
  3. Good Clinical Practice (GCP) Training
  4. Data and Safety Monitoring of Clinical Trials
  5. Dissemination of NIH-Funded Clinical Trial Information

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**